Chiesi Global Rare Diseases Announces Health Canada Grants Priority Review for FILSUVEZ® (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa
Priority review recognizes the serious nature of epidermolysis bullosa (EB) and the urgent need for continued evaluation of potential treatment options
If approved, FILSUVEZ has the potential to become the first therapy approved by Health Canada specifically for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa
With the establishment of Chiesi Canada as an affiliate of Chiesi Group in January 2026, Chiesi Canada aims to support people living with rare diseases across Canada as part of the Company's legacy of care spanning generations
PARMA, Italy and WOODBRIDGE, Ontario, June 09, 2026 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced that Health Canada has accepted the New Drug Submission (NDS) for FILSUVEZ® (birch triterpenes) topical gel for priority review for the proposed indication of the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in patients 6 months of age and older. Under Health Canada’s priority review pathway, the NDS is subject to an accelerated review timeline of approximately 180 days, in comparison to the traditional 300-day timeline.
Epidermolysis bullosa (EB) is a rare genetic disorder characterized by extremely fragile skin, chronic wounds, and significant pain, which can be a substantial burden on both patients and caregivers. Health Canada grants Priority Review to therapies intended to treat, prevent, or diagnose serious or life-threatening conditions where there are limited or no comparable treatment options, or where the therapy offers a meaningful improvement over existing care. This designation reflects Health Canada’s determination that the submission meets the criteria for accelerated review in an area of serious medical need for people living with EB in Canada.
“Priority Review acceptance by Health Canada marks an important regulatory milestone in the review for FILSUVEZ in Canada for people living with this rare, genetic, and often debilitating condition,” said Mitch Goldman, Senior Vice President, R&D, Chiesi Global Rare Diseases. “EB has historically been characterized by limited research and treatment options, but the field is evolving, and so are we. With our history in Canada as a center for research and development, and now as an affiliate, we are proud to contribute to progress for the community and privileged to partner with local regulators, patients, caregivers, and clinicians. We are hopeful that this milestone brings us closer to our goal of advancing rare disease care in Canada and supporting those living with EB.”
“For individuals and families living with EB, everyday life can involve significant challenges, from managing chronic pain to undertaking complex and time-intensive wound care,” said Erin Hoyos, Executive Director, DEBRA Canada. “Health Canada’s Priority Review of FILSUVEZ is an important milestone for the EB community and reflects continued progress in the evaluation of potential treatment options for people living with this condition in Canada.”
“Health Canada’s acceptance of this submission for Priority Review of FILSUVEZ highlights the importance of continued scientific advancement and additional therapeutic options for the EB community,” said Dr. Irene Lara-Corrales, MD, MSc, Paediatric Dermatologist at The Hospital for Sick Children (SickKids) in Toronto. “Epidermolysis bullosa remains highly challenging to manage, with patients often experiencing recurrent wounds, pain, infections, and other serious complications throughout their lives. The disease can also place a substantial physical, emotional, and caregiving burden on patients and families, often requiring ongoing multidisciplinary care and support. An approved therapy in Canada for individuals living with EB would represent an important potential advancement for the community.”
The submission is supported by data from the pivotal Phase 3 trial, EASE, which was published in the British Journal of Dermatology in 2023, that assessed the safety and efficacy of FILSUVEZ in patients with dystrophic and junctional epidermolysis bullosa, with a 24-month open-label follow-up period.1,2
The safety and efficacy of FILSUVEZ for the proposed indication remain under review by Health Canada, and FILSUVEZ has not received market authorization in Canada. FILSUVEZ has been approved by the U.S. Food and Drug Administration (2023) and the European Commission (2022) for the treatment of wounds associated with dystrophic and junctional EB. FILSUVEZ was officially registered by the Australian Register of Therapeutic Goods (ARTG) on May 5, 2026.
About Epidermolysis Bullosa
Epidermolysis bullosa (EB) is a rare genetic disorder characterized by extreme skin fragility and blistering. Severe forms lead to chronic blisters, ulcerations, scarring, joint contractures, esophageal strictures, a high risk of squamous cell carcinoma, infections and premature death.3
Epidermolysis Bullosa is a group of rare, inherited skin fragility disorders in which the skin is very weak and fragile. Even minor friction to the skin can cause painful blisters and open wounds that are slow to heal and can lead to significant scarring.3 Not only does EB affect the external skin, but the lining of the mouth, throat, eyes, and the digestive system.4 There are four main types of EB and they range in how severely they affect a person. The most severe forms are junctional EB (JEB), and dystrophic EB (DEB). These severe EB subtypes may be accompanied by multiple complications (e.g. sepsis, failure to thrive, severe anemia, cancer) leading to a reduced lifespan. People with EB must take extraordinary measures to protect their fragile skin, and despite their efforts, many live with chronic wounds all over their body. These wounds are extremely painful and itchy.4 Pain can be persistent and severe in EB patients.5 Globally, an estimated 500,000 people are living with EB.6
About EASE Trial
The EASE Study was a Phase III, double-blind, randomized, vehicle-controlled trial conducted to assess a potential treatment for inherited forms of EB, including dystrophic and junctional subtypes. The subjects were randomized and treated for three months in a double-blind manner with either Oleogel-S10 (birch triterpenes) or a placebo gel consisting of refined sunflower oil, yellow beeswax and carnauba wax. The respective gel was applied in a 1 mm thick layer to all wounds each time the wound dressing was changed (every 1 to 4 days).
A superficial wound with an area of 10 to 50 cm2 was selected as the target wound by the investigator at the start of the study. This wound was used to determine the primary efficacy endpoint: the proportion of patients in whom the target wound had completely closed for the first time by day 45. After completion of the double-blind phase of the study, it was continued as an open-label study, and all patients were treated with Oleogel-S10.
The primary efficacy endpoint was achieved in 41.3 percent of patients in the verum group and in 28.9 percent of patients in the placebo group.
Side effects occurred with similar frequency in both comparison groups and were mostly mild to moderate. The most frequently reported treatment-related AE was wound complication (13.8% in the Filsuvez group and 14.9% in the placebo group).1,7,8
About Chiesi Group
Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company's mission is to improve people's quality of life and act responsibly towards both the community and the environment.
By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi's commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.
With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group's research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.
For more information visit www.chiesi.com
About Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system.
For more information visit www.chiesirarediseases.com.
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Chiesi Global Rare Diseases Media Contact
Sky Striar
LifeSci Communications
Email: sstriar@lifescicomms.com
References
1) Kern JS, Sprecher E, Fernandez MF, Schauer F, Bodemer C, Cunningham T, Löwe S, Davis C, Sumeray M, Bruckner AL, Murrell DF; EASE investigators. Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study. Br J Dermatol. 2023 Jan 23;188(1):12-21. doi: 10.1093/bjd/ljac001. PMID: 36689495.
2) Fine, J.-D., Johnson, L. B., Weiner, M., Suchindran, C., & the Epidermolysis Bullosa Clinical Characterization and Outcomes Database Investigators. (2023). Inherited epidermolysis bullosa: Updated recommendations on diagnosis and classification. British Journal of Dermatology, 188(1), 12–18.
3) Denyer J, Pillay E, Clapham J. Best practice guidelines for skin and wound care in epidermolysis bullosa. An International Consensus. Wounds International, 2017
4) Fine JD. Inherited epidermolysis bullosa. Orphanet Journal of Rare Diseases2010; 5(12): doi.org/10.1186/1750-1172-5-12. 5
5) Tabor A, Pergolizzi JV, Marti G, et al. Raising awareness among healthcare providers about Epidermolysis Bullosa and advancing toward a cure. J ClinAesthet Dermatol 2017; 10(5): 36-48
6) Epidermolysis Bullosa Research Partnership. “What Is EB?” EB Research Partnership, https://www.ebresearch.org/what-is-eb.html
7) Murrell DF, Bodemer C, Bruckner AL, Cunningham T, Davis C, Fernández MF, Kiritsi D, Maher L, Sprecher E, Torres-Pradilla M, Kern JS. Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the phase III EASE study. Br J Dermatol. 2025 May 19;192(6):1007-1017. doi: 10.1093/bjd/ljaf022. PMID: 39821055.
8) Data on File, Chiesi Global Rare Diseases, EASE Study CSR, March 2021.
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